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Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia

NCT00883740 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2021-01-25

Study results available
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Summary

The purpose of the study is to demonstrate the effect of Lyrica on Wake after sleep onset in subjects with fibromyalgia with sleep maintenance disturbance (on polysomnogram)

Conditions

  • Fibromyalgia
  • Sleep Disorders

Interventions

DRUG

Pregabalin

Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks titrated to 300-450 mg/day

DRUG

Placebo

Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States
  • Canada
  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00883740 on ClinicalTrials.gov